5 results
The primary objective of this investigation is to evaluate the performance of the DISCOVER Artificial Cervical Disc in the treatment of cervical disc disease by measuring the function assessed via Neck Disability Index (NDI) and neurological…
- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection- To assess…
The primary objective of this investigation is to evaluate the performance of the DISCOVER Artificial CervicalDisc in the treatment of cervical disc disease by measuring the function assessed via Neck Disability Index(NDI) and neurological function…
- To assess the safety and (local) tolerability of test compound following single rising dose administration by subcutaneous injection- To determine FSH pharmacokinetic parameters including Cmax and AUC0-last of test compound following single rising…
Pilot study:Primary objective: feasibilitySecondary objectives: response rate, time to progression, overall survival and quality of life.Phase II study:Primary objective: efficacy.Secondary objectives: toxicity, especially grade 3 and 4 toxicities,…